Albinterferon alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis c virus genotype 2 or 3

David R. Nelson, Yves Benhamou, Wanlong Chuang, Eric J. Lawitz, Maribel Rodrigueztorres, Robert Flisiak, Jens W.F. Rasenack, Wiesaw Kryczka, Chuanmo Lee, Vincent G. Bain, Stephen Pianko, Keyur Patel, Patrick W. Cronin, Erik Pulkstenis, G. Mani Subramanian, John G. McHutchison

Producción científica: Articlerevisión exhaustiva

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Resumen

Background & Aims A phase 3 active-controlled study was conducted to assess the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of recombinant human albumin and interferon alfa-2b, in patients with chronic hepatitis C virus (HCV) genotype 2/3. Methods In all, 933 patients were randomized to open-label subcutaneous treatment with pegylated interferon-alfa-2a (Peg-IFNalfa-2a) 180 μg/wk, or albIFN 900 or 1200 μg every 2 weeks for 24 weeks, each administered with oral ribavirin 800 mg/day. The primary end point of the study was sustained virologic response (SVR) (HCV-RNA level, <15 IU/mL at week 48). During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μg to 900 μg, impacting 38% of this treatment arm. Results By intention-to-treat analysis, SVR rates were 84.8% (95% confidence interval, 80.4%88.6%), 79.8% (95% confidence interval, 74.9%84.1%), and 80.0% (95% confidence interval, 75.1%84.3%) with Peg-IFNalfa-2a, and albIFN 900 and 1200 μg, respectively. The primary hypothesis of noninferiority of SVR was established for albIFN 900 μg (P = .009) and 1200 μg (P = .006). Independent positive predictors of SVR by multivariate regression analysis were pretreatment HCV-RNA level less than 400,000 IU/mL, age younger than 45 years, body mass index less than 30 kg/m2, genotype 2, normal γ-glutamyl transpeptidase and increased alanine aminotransferase levels at baseline, fibrosis stage F0F2, no steatosis, and Asian geographic region (Peg-IFNalfa-2a only). The 3 treatment groups showed similar rates of serious (7%8%) and severe (13%16%) adverse events, and discontinuations owing to adverse events (3.6%5.5%). Conclusion Albinterferon alfa-2b 900 μg every 2 weeks provides an alternative efficacious treatment option in patients with chronic HCV genotype 2 or 3.

Idioma originalEnglish (US)
Páginas (desde-hasta)1267-1276.e4
PublicaciónGastroenterology
Volumen139
N.º4
DOI
EstadoPublished - oct 2010

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

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